EVO101 Cream for Hidradenitis Suppurativa

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: Virginia Clinical Research, Inc.

Must not be taking: Biologics, JAK inhibitors

Disqualifiers: Severe HS, Pregnancy, Alcohol abuse, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn if drug EVO101 works to treat mild to moderate hidradenitis suppurativa in adults. The main questions it aims to answer are: Does drug EVO101 lower the total number of lesion a participant has from the first visit to the last visit. What medical problems do participants have when applying drug EVO101 Does a participant perceive a change in their hidradenitis suppurativa symptoms based on patient reported outcome questionnaires. Participants will: Apply EVO101 topical cream 0.1% topically Visit the clinic four times unless the first and second appointment have to be done separately then there will be five clinic visits and one phone call over a twelve week period. Keep a dosing diary

Will I have to stop taking my current medications?

You may need to stop certain medications before joining the trial. Specifically, you cannot use antibiotics, certain topical treatments, or systemic therapies for hidradenitis suppurativa during the study. Some medications require a 'washout' period (time without taking them) before starting the trial.

How is the drug EVO101 Cream unique for treating Hidradenitis Suppurativa?

EVO101 Cream is unique because it may incorporate a novel combination of ingredients, such as hyaluronic acid and bacterial-wall-derived glycoproteins, which have shown effectiveness in rebalancing skin microbiota and reducing symptoms in other skin conditions like seborrheic dermatitis. This approach could offer a new mechanism of action compared to traditional treatments for Hidradenitis Suppurativa. ^{1 2 3 4 5}

Research Team

Eligibility Criteria

Adults with mild to moderate hidradenitis suppurativa, a skin condition that causes small, painful lumps under the skin. Participants must be willing to apply a topical cream, visit the clinic up to five times, and keep a dosing diary over twelve weeks.

Inclusion Criteria

For women of childbearing potential: agree to remain abstinent or use a highly effective contraceptive method during the treatment period and for at least 30 days after the last application of study drug

I am 18 years old or older.

I have been diagnosed with hidradenitis suppurativa for at least 3 months.

Exclusion Criteria

I am not pregnant or breastfeeding.

I haven't taken certain medications or treatments recently.

Very severe, severe, minimal, or clear HS-PGA

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants apply EVO101 topical cream 0.1% and visit the clinic four to five times over a twelve-week period

12 weeks

4-5 visits (in-person), 1 phone call

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• EVO101 (Topoisomerase I Inhibitor)

Trial Overview The trial is testing EVO101 topical cream (0.1%) for treating hidradenitis suppurativa. It aims to see if this treatment reduces the number of lesions from first to last visit and improves symptoms based on patient questionnaires.

Participant Groups

Group I: Open label EVO101 topical cream 0.1% Experimental Treatment 1 Intervention

All eligible subjects will receive open label EVO101 topical cream 0.1%

Who Is Running the Clinical Trial?

Virginia Clinical Research, Inc.

Lead Sponsor

Trials

5

Recruited

160+

Evommune, Inc.

Industry Sponsor

Trials

5

Recruited

380+

Findings from Research

In a study involving 40 children aged 5 to 11, alclometasone dipropionate cream 0.05% was found to be slightly more effective than hydrocortisone butyrate cream 0.1% in treating atopic dermatitis, with an average improvement of 76% compared to 70%.

At the end of the 2-week treatment, 19 out of 20 children using alclometasone showed significant improvement in their symptoms, while 16 out of 20 children using hydrocortisone did, indicating that both treatments are effective but alclometasone may offer better results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical comparison of alclometasone dipropionate cream 0.05% with hydrocortisone butyrate cream 0.1% in the treatment of atopic dermatitis in children. Lassus, A.[2017]

In a 6-week study involving 75 participants with moderate to severe seborrheic dermatitis, the new EDS cream significantly reduced the severity of symptoms, with an 88% improvement in the Investigator Global Assessment score by week 6.

The treatment not only alleviated skin symptoms but also positively influenced the skin microbiota, increasing beneficial Cutibacterium acnes while decreasing harmful Staphylococcus, indicating a rebalancing effect on the skin's microbial environment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a cream containing 5% hyaluronic acid mixed with a bacterial-wall-derived glycoprotein, glycyrretinic acid, piroctone olamine and climbazole on signs, symptoms and skin bacterial microbiota in subjects with seborrheic dermatitis of the face. Puviani, M., Campione, E., Offidani, AM., et al.[2020]

In a phase II study involving 20 patients with mild to moderate atopic eczema, both the new mometasone furoate cream (Monovo®) and the existing fatty cream (Ecural®) were found to be equally effective and well tolerated.

Patients preferred the new formulation due to its improved cosmetic properties, suggesting that while both treatments are effective, the new cream may enhance patient satisfaction and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and patient-reported outcomes of a new mometasone cream treating atopic eczema. Ruzicka, T., Willers, C., Wigger-Alberti, W.[2015]

The developed aspasomal gel of Mometasone Furoate showed a sustained drug release over 24 hours, significantly longer than the 5 hours observed with the marketed cream, indicating improved efficacy in treating psoriasis.

In vivo studies on Wistar rats demonstrated that the aspasomal gel did not cause skin irritation or inflammation, suggesting a safe delivery system for the treatment of psoriasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mometasone furoate-loaded aspasomal gel for topical treatment of psoriasis: formulation, optimization, in&#160;vitro and in&#160;vivo performance. Shinde, G., Desai, P., Shelke, S., et al.[2022]

In a study of 331 patients with tinea cruris or tinea corporis, SCH 370 cream (1% clotrimazole/0.05% betamethasone dipropionate) showed faster therapeutic activity and better clinical results compared to clotrimazole or betamethasone alone, particularly after one week of treatment.

All treatments were found to be safe, with no unexpected or serious adverse effects reported, indicating that SCH 370 cream is a well-tolerated option for treating these fungal infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SCH 370 (clotrimazole-betamethasone dipropionate) cream in patients with tinea cruris or tinea corporis. Katz, HI., Bard, J., Cole, GW., et al.[2014]

References

1. England pubmed.ncbi.nlm.nih.gov

Clinical comparison of alclometasone dipropionate cream 0.05% with hydrocortisone butyrate cream 0.1% in the treatment of atopic dermatitis in children. [2017]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Effects of a cream containing 5% hyaluronic acid mixed with a bacterial-wall-derived glycoprotein, glycyrretinic acid, piroctone olamine and climbazole on signs, symptoms and skin bacterial microbiota in subjects with seborrheic dermatitis of the face. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy and patient-reported outcomes of a new mometasone cream treating atopic eczema. [2015]

4. England pubmed.ncbi.nlm.nih.gov

Mometasone furoate-loaded aspasomal gel for topical treatment of psoriasis: formulation, optimization, in&#160;vitro and in&#160;vivo performance. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

SCH 370 (clotrimazole-betamethasone dipropionate) cream in patients with tinea cruris or tinea corporis. [2014]